Product code HFM— Obstetrics/Gynecology

FDA has cleared 23 devices under product code HFM between 1984 and 2014, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20141 clearance
• 20061 clearance
• 20041 clearance
• 20021 clearance
• 20002 clearances
• 19961 clearance
• 19951 clearance
• 19931 clearance
• 19912 clearances
• 19903 clearances
• 19893 clearances
• 19882 clearances
• 19862 clearances
• 19842 clearances

• Ventrex, Inc.2 clearances
• Tokos Medical Corp.2 clearances
• Corometrics Medical Systems, Inc.2 clearances
• Aequitron Medical, Inc.2 clearances
• Utah Medical Products, Inc.1 clearance
• Scientific Device Manufacturer, LLC1 clearance
• Precision Dynamics Corp.1 clearance
• Pediatric Diagnostic Service1 clearance
• Orion Industries1 clearance
• Ocg Systems, Inc.1 clearance

• K140163 — KOALA TOCOClinical Innovations, LLC·2014-05-29
• K061044 — FEATHERLITE AQUA TOCODYNAMOMETERVentrex, Inc.·2006-07-12
• K040392 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGAmerican I.V. Products, Inc.·2004-09-14
• K013477 — TOCO LITE, MODEL TD-01Ventrex, Inc.·2002-01-17
• K994353 — SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565Precision Dynamics Corp.·2000-03-22
• K992811 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGEpic Medical Equipment Services, Inc.·2000-01-18
• K954847 — DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIESOcg Systems, Inc.·1996-05-22
• K952579 — TOCO TRANSDUCERScientific Device Manufacturer, LLC·1995-08-04
• K920152 — BUBBLE TOCOUtah Medical Products, Inc.·1993-05-26
• K910282 — MEDI-TRACE(R) DISPOSABLE TOCOTONOMETERGraphic Controls Corp.·1991-03-29
• K904691 — AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYSTAir-Shields Vickers, Inc.·1991-02-19
• K903623 — MODEL600 UTERINE ACTIVITY MONITORCorometrics Medical Systems, Inc.·1990-11-07
• K902104 — ORION WATCHGUARDOrion Industries·1990-10-25
• K894030 — MODEL 37 UTERINE CONTRACTION ACTIVITY MONITORHealthdyne, Inc.·1990-01-22
• K893770 — TERM GUARD II DEVICETokos Medical Corp.·1989-11-03
• K891997 — CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCERCorometrics Medical Systems, Inc.·1989-06-08
• K882080 — MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.Aequitron Medical, Inc.·1989-03-01
• K873150 — PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.Pediatric Diagnostic Service·1988-03-11
• K874631 — HEALTHPHONE TOCO MODELCarelink·1988-03-11
• K860933 — AIR-CUSHION TOCOTONOMETERInternational Biomedics, Inc.·1986-07-09
• K853856 — EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMETAequitron Medical, Inc.·1986-03-12
• K843011 — TERM GUARD 5000 UTERINE ACTIVITYTokos Medical Corp.·1984-11-01
• K840747 — TOCO DATA TELEPHONE TRANSMITTER DT100PAdvantage Medical Systems, Inc.·1984-06-19